The Intention-to-treat Effect of Bridge Therapies in the Setting of Milan-in Patients
NCT03723304 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1083
Last updated 2018-10-29
Summary
In patients with hepatocellular cancer (HCC) meeting the Milan Criteria (MC), the usefulness of loco-regional therapies (LRT) in the context of liver transplantation (LT) is still debated. The inconsistent literature data are the result of initial selection biases among treated and untreated patients. In order to overcome these shortcomings, an inverse probability of treatment weighting (IPTW) analysis was done in a large patient cohort. After using a competing-risk analysis, the primary end-point of the study aims at identifying the risk factors of HCC-specific LT failure, defined as pre-LT tumour-related drop-out or post-LT recurrence.
Conditions
- Liver Cancer
- Transplant; Failure, Liver
Interventions
- PROCEDURE
-
Bridging followed by transplant
Trans-arterial chemoembolization or percutaneous alcohol injection or radio-frequency ablation during the waiting time followed by liver transplant
- PROCEDURE
-
Direct liver transplant
Direct liver transplant (no neoadjuvant approaches during the waiting time period)
Sponsors & Collaborators
-
European Hepatocellular Cancer Liver Transplant Group
lead OTHER
Principal Investigators
-
Quirino Lai, MD PhD · UCL Brussels
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-01
- Primary Completion
- 2018-10-15
- Completion
- 2018-10-15
Countries
- Belgium
Study Locations
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